At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,057 enrolled
Drug / intervention
VIR-7831 (sotrovimab) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II/III Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients
In Brief
A Phase 3 clinical trial evaluating VIR-7831 (sotrovimab) and Placebo for Covid19. Completed, enrolled 1,057 participants across 91 sites in 7 countries.
Detailed Summary
This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesAustria, Brazil, Canada, Peru, Spain, United Kingdom, United States
CollaboratorsGlaxoSmithKline
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartAug 2020
First PostedSep 2020
Primary CompletionApr 2021
Study CompletionSep 2021
TodayJul 2026
First PostedSep 10, 2020
Enrollment StartAug 27, 2020
Primary CompletionApr 8, 2021
Study CompletionSep 2, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.8 years ago
Interventions
VIR-7831 (sotrovimab)biological
VIR-7831 (sotrovimab) given by intravenous infusion (single dose)
Placebodrug
Sterile normal saline (0.9% NaCl) given by intravenous infusion (single dose)